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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K844996
Device Name PARAGON TRICHECK ELECTROPHORESIS CONTROL
Applicant
Beckman Instruments, Inc.
2500 Harbor Blvd.
P.O. Box 3100
Fullerton,  CA  92634
Applicant Contact JACK E SOROKIN
Correspondent
Beckman Instruments, Inc.
2500 Harbor Blvd.
P.O. Box 3100
Fullerton,  CA  92634
Correspondent Contact JACK E SOROKIN
Regulation Number862.1660
Classification Product Code
JJY  
Date Received12/26/1984
Decision Date 02/06/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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